Inspire Reports Second Quarter 2006 Financial Results; Second Quarter 2006 Revenue Increases 40% from Second Quarter 2005.DURHAM, N.C. -- Inspire Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ISPH ISPH Inspire Pharmaceuticals, Inc. ) today reported financial results for the second quarter ended June 30, 2006. Total revenue for the second quarter of 2006 was $13.4 million compared to $9.6 million for the second quarter of 2005. Co-promotion revenue from net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight of Elestat(R) (epinastine HCl ophthalmic solution ophthalmic solution n. A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. ) 0.05% was $9.4 million, an increase of 19% compared to $7.9 million recognized in the second quarter of 2005. During the second quarter of 2006, the Company achieved its 2006 net sales target level for Elestat, thereby allowing the recognition of $1.8 million of previously deferred revenue on net sales of Elestat. Co-promotion revenue on net sales of Restasis(R) (cyclosporine ophthalmic emulsion cyclosporine ophthalmic emulsion Sandimmun (UK), Restasis Pharmacologic class: Polypeptide antibiotic Therapeutic class: Immunosuppressant Pregnancy risk category C FDA Boxed Warning) 0.05% for the second quarter of 2006 was $4.0 million, an increase of 133% compared to $1.7 million recognized in the second quarter of 2005. The increases in second quarter 2006 co-promotion revenues, as compared to 2005, were related to the continued patient and physician acceptance and usage of Elestat and Restasis in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , a more severe Spring allergy season and an increase in Inspire's entitled percentage of net sales of Restasis effective in April 2006.Total revenue for the six months ended June 30, 2006 was $18.9 million, as compared to $11.5 million for the same 2005 period. Co-promotion revenues were $17.7 million, an increase of $6.2 million compared to the same period in 2005. In addition, the Company recognized $1.25 million in development milestone revenue received pursuant to a collaborative research agreement with Santen Pharmaceutical Co., Ltd. related to Santen's completion of Phase 2 development of diquafosol tetrasodium for dry eye disease in Japan. Operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the second quarter of 2006 totaled $20.0 million, as compared to $15.3 million for the same period in 2005. The increase in second quarter 2006 operating expenses, as compared to 2005, was primarily due to increases in research and development expenses of $2.4 million and general and administrative expenses of $1.5 million. The increased research and development expenses were attributable to increased costs for advancing our cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. , seasonal allergic rhinitis seasonal allergic rhinitis, n See hay fever. seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis. , glaucoma glaucoma (glôkō`mə), ocular disorder characterized by pressure within the eyeball caused by an excessive amount of aqueous humor (the fluid substance filling the eyeball). and cardiovascular programs. The increase in general and administrative expenses is due to increased legal and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. associated with the ongoing stockholder litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and SEC investigation and increased personnel costs partially due to implementation of Statement of Financial Accounting Standards No. 123(R). Operating expenses for the six months ended June 30, 2006 were $40.6 million, as compared to $31.4 million for the same period in 2005. Effective January 1, 2006, the Company adopted the fair value recognition provisions of Statement of Financial Accounting Standards No. 123 (R), "Share-Based Payment". Accordingly, the Company has recorded approximately $343,000 and $703,000 of stock-based compensation expense, related to stock options issued under the Company's stock option plans, in its operating expenses for the second quarter and six months ended June 30, 2006, respectively. For the quarter ended June 30, 2006, the Company reported a net loss of $5.4 million, or ($0.13) per share, as compared to a net loss of $4.7 million, or ($0.11) per share, for the same period in 2005. The net loss for the six months ended June 30, 2006 was $19.4 million, or ($0.46) per share, as compared to a net loss of $18.0 million, or ($0.43) per share for the same period in 2005. Cash, cash equivalents and investments totaled $99.2 million at June 30, 2006, reflecting a $23.1 million utilization of cash, cash equivalents and investments during the first half of 2006 or a cash burn averaging approximately $3.9 million per month. Based upon the current results and trends, the Company reaffirms its previously issued 2006 operating guidance of aggregate revenue of $31-$39 million and operating expenses of $77-$86 million, which includes approximately $2 million of stock-based compensation expense. Christy L. Shaffer, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Inspire, stated, "The second quarter was productive for Inspire on multiple fronts. We generated a record level of revenues from increased use of Elestat during the Spring allergy season and the increased awareness and success of Restasis for dry eye. We also made good progress in our Respiratory/Allergy clinical programs, including initiating a Phase 3 trial in cystic fibrosis (CF) and conducting a pre-IND meeting with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regarding our new seasonal allergic rhinitis program." Recent Updates Include (April 1, 2006 through August 8, 2006): Research & Development --Initiated a Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. to evaluate denufosol tetrasodium in patients with mild CF lung disease lung disease Pulmonary disease Pulmonology Any condition causing or indicating impaired lung function Types of LD Obstructive lung disease–↓ in air flow caused by a narrowing or blockage of airways–eg, asthma, emphysema, chronic bronchitis; ; --Announced plans to file an Investigational New Drug (IND) application and begin Phase 2 clinical testing of intranasal in·tra·na·sal adj. Within the nose. epinastine for the treatment of seasonal allergic rhinitis; and --Initiated a Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. in April 2006 to evaluate INS INS abbr. 1. Immigration and Naturalization Service 2. International News Service Noun 1. INS 50589 Antiplatelet an·ti·plate·let adj. Acting against or destroying blood platelets. antiplatelet directed against or destructive to blood platelets; inhibiting platelet function. in patients undergoing coronary artery bypass graft coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there ) surgery; this trial was terminated by Inspire in August 2006 per the recommendation of its independent Data Monitoring Committee. Sales and Marketing --Continued Elestat ranking as the second most prescribed allergic conjunctivitis allergic conjunctivitis n. Conjunctivitis caused by an allergic reaction to a substance. Also called atopic conjunctivitis. allergic conjunctivitis product in the United States, achieving 10% in total weekly prescription volume and 9% of total year-to-date 2006 prescription volume based upon National Prescription data from IMS Health IMS Health (NYSE: RX) is an international consulting and data services company that supplies the pharmaceutical industry with sales data and consulting services. IMS Health was founded in 1954 by Bill Frohlich and David Dubow. , as measured for the week ending July 14, 2006; --In collaboration with Allergan, Inc., increased prescription volume of Restasis, which is the only approved prescription treatment for dry eye in the United States; Allergan reported second quarter 2006 net sales of Restasis of $66 million, representing a 42% increase over 2005; and --Inspire's entitled percentage of U.S. net sales of Restasis increased in April 2006 as provided by the licensing agreement with Allergan. Corporate --Announced the hiring of two new Vice Presidents, Bart J. Dunn as Vice President, Business Development and Raymond W. Hines as Vice President, Associate General Counsel; and --Granted restricted stock units Restricted stock units Similar to restricted stock. However, the unit represents a promise that employees will receive stock in the future. The units do not pay dividends until the stock is vested. representing shares of common stock of the Company to each of the Corporate Officers pursuant to an action on July 21, 2006 by the Compensation Committee of the Board of Directors. Inspire will host a conference call and live webcast to discuss its second quarter 2006 financial results on Tuesday, August 8th at 10:00 a.m. ET. To access the conference call, U.S. participants may call (877) 780-2276 and international participants may call (973) 582-2757. The conference ID number is 7639281. A live webcast and replay of the call will be available on Inspire's website at www.inspirepharm.com. A telephone replay of the conference call will be available until August 22, 2006. To access this replay, U.S. participants may call (877) 519-4471 and international participants may call (973) 341-3080. The conference ID number is 7639281. About Inspire Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. The research and development programs of Inspire are driven by extensive scientific experience in the therapeutic areas of ophthalmology and respiratory/allergy, and supported by expertise in the field of P2 receptors. Inspire is currently developing drug candidates for dry eye, cystic fibrosis and allergic rhinitis Allergic Rhinitis Definition Allergic rhinitis, more commonly referred to as hay fever, is an inflammation of the nasal passages caused by allergic reaction to airborne substances. . Inspire's U.S. specialty sales force promotes Elestat(R) (epinastine HCI (Human Computer Interaction) Refers to the design and implementation of computer systems that people interact with. It includes desktop systems as well as embedded systems in all kinds of devices. ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis(R) (cyclosporine ophthalmic emulsion) 0.05% for dry eye, ophthalmology products developed by Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan. For more information, visit www.inspirepharm.com. Forward-Looking Statements The forward-looking statements in this news release relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc management's expectations and beliefs are based on preliminary information and management assumptions. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, the seasonality of Elestat, intellectual property rights, adverse litigation developments, adverse developments in the U.S. Securities and Exchange Commission (SEC) investigation, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof. --Financial tables follow --
INSPIRE PHARMACEUTICALS, INC.
Condensed Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
Three Months Six Months
Ended June 30, Ended June 30,
----------------- -------------------
2006 2005 2006 2005
-------- -------- --------- ---------
Revenues:
Revenue from product
co-promotion $13,437 $9,607 $17,655 $11,458
Collaborative research
agreements - - 1,250 -
-------- -------- --------- ---------
Total revenue
13,437 9,607 18,905 11,458
Operating expenses:
Research and development 9,173 6,739 18,282 12,791
Selling and marketing 6,457 5,728 13,553 13,097
General and administrative 4,334 2,803 8,780 5,491
-------- -------- --------- ---------
Total operating expenses 19,964 15,270 40,615 31,379
-------- -------- --------- ---------
Loss from operations (6,527) (5,663) (21,710) (19,921)
Other income (expense):
Interest income 1,185 1,045 2,393 2,001
Interest expense (28) (38) (58) (78)
Loss on investments (7) - (29) -
-------- -------- --------- ---------
Other income 1,150 1,007 2,306 1,923
-------- -------- --------- ---------
Net loss $(5,377) $(4,656) $(19,404) $(17,998)
======== ======== ========= =========
Basic and diluted net loss per
common share $(0.13) $(0.11) $(0.46) $(0.43)
======== ======== ========= =========
Weighted average common shares
used in computing basic and
diluted net loss per common
share 42,220 42,069 42,216 42,003
======== ======== ========= =========
INSPIRE PHARMACEUTICALS, INC.
Selected Balance Sheet Information
(in thousands)
June 30, December 31,
2006 2005
------------ -------------
Cash, cash equivalents and investments $99,198 $122,323
Receivables from Allergan 11,295 4,898
Working capital 87,523 99,265
Total assets 115,050 132,446
Total stockholders' equity 100,009 118,689
Shares of common stock outstanding 42,237 42,211
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